NCT03977714: INPERIO

Non-invasive Solution for Periodontal and Peri-implant Diseases (INPERIO)

Completed NA Last updated 8 July 2022

What this trial tests

NA trial testing Zirconia implants with G3-coated abutments (test implants and abutments) in Peri-Implantitis in 24 participants. Completed in 4 July 2022.

Timeline

2 August 2019

Primary endpoint
4 July 2022

4 July 2022

Quick facts

Lead sponsor	Nanoker Research S.L.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	24
Start date	2 August 2019
Primary completion	4 July 2022
Estimated completion	4 July 2022
Sites	1 location across Spain

Drugs / interventions tested

• Zirconia implants with G3-coated abutments (test implants and abutments)
• Zirconia implants with control abutments (test implants, negative control abutments)
• Titanium implants with G3-coated abutments (control implants, test abutments)
• Titanium implants with control abutments (negative control implants and abutments)
• Zirconia implants and titanium implants, for histological and histomorphometric evaluation.

Conditions studied

• Peri-Implantitis — all drugs for Peri-Implantitis →

Sponsor

Nanoker Research S.L.

Who can join

Adults 18 to 80, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

DESCRIPTION: The Investigational Product "A-Ce toughened TZP nanocomposite implant" is a Medical Device (MD) intended for the dental rehabilitation of edentulous sites with fixed prosthesis. The "G3®-coated NK2® abutment" is a MD intended for the prevention of peri-implant bone loss due to peri-implantitis. The MD are for dental use and will be used exclusively on subjects who have signed an informed consent form and by approved study investigators.

OBJECTIVES: (a) To evaluate the safety and performance of the "A-Ce toughened TZP nanocomposite Implant" for its intended medical application purpose in the context of successful osseointegration of zirconia-based dental implants. (b) To evaluate the safety and performance of the "G3®-coated NK2® abutment" for its intended purpose in the context of peri-implantitis prevention. (c) To obtain the regulatory CE Mark Certification status for both medical devices.

TYPE OF INVESTIGATION: Randomized double-blind (patient, appraiser) controlled study.

CENTER/COUNTRY: Instituto de Cirugía Oral Avanzada (ICOA), Madrid, Spain

GROUPS:

Group A: 30 zirconia implants with 30 G3-coated abutments (test implant and abutment) Group B: 30 test implants with 30 uncoated (control) abutments Group C: 30 Ti implants (control) with 30 test abutments Group D: 30 control implants with 30 control abutments Group E: 3 test implants and 3 control implants, for histological/histomorphometric evaluation.

COMPARATIVE DEVICE: Commercial Ti dental implant.

STATISTICAL METHODOLOGY:

H0 : INPERIO performs worse (with statistical significance) than the commercial devices.

* Test implants achieve a higher failure rate than Ti implants.
* The clinical osseointegration parameter values are worse with statistical significance for test implants than for control implants.
* Histological and histomorphometric analysis shows worse quality and quantity of osseointegration for test implants than for Ti implants.

H1: There is no statistical significance between INPERIO and the commercial solution or INPERIO performs better (with statistical significance) than the commercial Ti implants.

* Test implants achieve the same failure rate or less than Ti implants.
* The clinical osseointegration parameter values are no different or are better with statistical significance for test implants than for control implants.
* The histological and histomorphometric analysis shows a similar or better quality and quantity of osseointegration for test implants than for Ti implants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.